title: A double-blind, randomized, comparative study to evaluate the efficacy and safety of zaleplon versus zolpidem in shortening sleep latency in primary insomnia.
abstract: BACKGROUND
  Benzodiazepines cause a high proportion of adverse effects while non-benzodiazepine compounds have demonstrated high efficacy and less adverse effects in patients with insomnia. The objective of this study was to compare the effectiveness and safety of non-BZ zaleplon and zolpidem in primary insomnia.
  
  
  METHODS
  This was a randomized, double-blind, active-controlled, double-dummy, comparative study. A total of 48 patients were enrolled, of which 45 patients completed the study. Patients who entered the study were required to take the study drug orally once daily at bedtime for two weeks. Each patient kept a sleep diary and answered a questionnaire. We used these documents to measure and evaluate changes from baseline to Week 2 in sleep latency, duration and quality of sleep, the number of awakenings and incidence of rebound insomnia.
  
  
  RESULTS
  The data revealed a significant decrease in sleep latency from baseline to Week 2 for patients receiving zaleplon 10 mg and zolpidem 10 mg. Patients receiving zaleplon exhibited a marginally greater, but not statistically significant, reduction in sleep latency than those who received zolpidem. There was no significant difference in the frequency of adverse effects between the zaleplon and zolpidem groups; however, during this clinical trial there was one lethal event caused by a traffic accident in the zaleplon group.
  
  
  CONCLUSIONS
  There was no significant difference between zaleplon and zolpidem in the efficacy of reducing sleep latency or adverse effects. A large pharmacovigilance study is needed before concluding that either zolpidem or zaleplon is free from next-day residual effects.
authors.affiliation: Sleep Center and Department of Psychiatry, Chang Gung Memorial Hospital at Linkou, Taoyuan, Taiwan, ROC.
authors.forename: Yu-Shu
authors.initials: YS
authors.lastname: Huang
authors.forename: Shih-Chieh
authors.initials: SC
authors.lastname: Hsu
authors.forename: Shen-Ing
authors.initials: SI
authors.lastname: Liu
authors.forename: Chih-Ken
authors.initials: CK
authors.lastname: Chen
mesh_terms: D000081:Acetamides / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011725:Pyridines / Q000009:adverse effects / Q000627:therapeutic use*; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use*; D012890:Sleep / Q000187:drug effects*; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D013375:Substance Withdrawal Syndrome / Q000209:etiology; D000077334:Zolpidem
chemical_list: D000081:Acetamides; D011725:Pyridines; D011743:Pyrimidines; D000077334:Zolpidem; C085665:zaleplon